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Clinical Research Associate (CRA)

Pharmavise Corporation

Role overview

Qualifications

  • Bachelor’s degree in a relevant field
  • 6+ years of experience in clinical research or a related industry
  • Experience as a Clinical Research Associate, Clinical Research Coordinator, or Clinical Research Assistant
  • 3+ years of experience in project management or a related role

Responsibilities

  • Oversee study-level project management tasks, including study maintenance, data lock, closeout, document review, and budget monitoring
  • Act as the primary liaison between internal study teams and external third-party organizations (TPOs)
  • Track and monitor safety, biomarker, pharmacokinetic (PK), anti-drug antibody (ADA) samples, imaging data, and connected device data
  • Manage and track clinical queries to ensure timely resolution

Key facts

Hard skills

Clinical Research Project Management Clinical Trial Management Systems gRPC Medidata Rave Veeva Oracle InForm Query Planning Accident Reporting

Other skills

  • Organizational Skills
  • Communication
  • Microsoft Excel

About the company

Pharmavise Corporation logo

Pharmavise Corporation

Management Consulting

♦𝐄𝐱𝐜𝐞𝐥𝐥𝐞𝐧𝐜𝐞 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐮𝐚𝐥𝐢𝐭𝐲♦: 𝐏𝐡𝐚𝐫𝐦𝐚𝐯𝐢𝐬𝐞, 𝐲𝐨𝐮𝐫 𝐬𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐜 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞𝐬, 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐚𝐧𝐝 𝐆𝐨𝐯𝐞𝐫𝐧𝐦𝐞𝐧𝐭 𝐬𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬 𝐩𝐚𝐫𝐭𝐧𝐞𝐫. 𝗔𝗯𝗼𝘂𝘁 𝘂𝘀 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻: We provide high-quality, cost-effective people and process solutions for your Quality, Regulatory, Engineering, Clinical, and Healthcare needs. Our company mantra 𝐄𝐗𝐂𝐄𝐋𝐋𝐄𝐍𝐂𝐄 𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐐𝐔𝐀𝐋𝐈𝐓𝐘. The safety and quality of the drugs and devices produced for patients are directly related to 2 things, 𝐑𝐎𝐁𝐔𝐒𝐓 𝐏𝐑𝐎𝐂𝐄𝐒𝐒 𝐚𝐧𝐝 𝐐𝐔𝐀𝐋𝐈𝐅𝐈𝐄𝐃 𝐏𝐄𝐎𝐏𝐋𝐄. 𝐖𝐞 𝐝𝐞𝐥𝐢𝐯𝐞𝐫 𝐛𝐨𝐭𝐡. 𝐃𝐢𝐟𝐟𝐞𝐫𝐞𝐧𝐭𝐢𝐚𝐭𝐨𝐫𝐬: ☑𝐇𝐢𝐠𝐡𝐥𝐲 𝐒𝐤𝐢𝐥𝐥𝐞𝐝 𝐓𝐞𝐚𝐦: Our team of experienced consultants with diverse backgrounds in life sciences, including scientists, researchers, and regulatory experts. The quality and expertise of our team significantly impact our client’s success. ☑𝐒𝐩𝐞𝐜𝐢𝐚𝐥𝐢𝐳𝐞𝐝 𝐄𝐱𝐩𝐞𝐫𝐭𝐢𝐬𝐞: We focus on specific niches within the life sciences, healthcare, and government sectors, such as pharmaceuticals, biotechnology, medical devices, regulatory affairs, medical research, and product development. This specialized expertise allows us to offer targeted and in-depth insights to our clients. ☑𝐂𝐮𝐬𝐭𝐨𝐦𝐢𝐳𝐞𝐝 𝐒𝐨𝐥𝐮𝐭𝐢𝐨𝐧𝐬: We offer tailored solutions that align with the specific requirements of each client, rather than one-size-fits-all approaches, demonstrating a commitment to meeting client needs. We do not require a long learning curve, which leads to a faster payback and a greater return on your investment. 𝗣𝗲𝗿𝗳𝗼𝗿𝗺𝗮𝗻𝗰𝗲 𝗛𝗶𝘀𝘁𝗼𝗿𝘆 Over 20 Technical Transfers and 30 product launches. 11 FDA remediations. Warning Letters and or Consent Decrees. Cost savings and increased efficiency of over 10MM for clients

Company details

IndustryManagement Consulting
Company size11 - 50

Links

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Job description

This is a remote position.

We are seeking experienced Clinical Research Associates (CRAs) to provide surge capacity support for ongoing clinical research projects. This role focuses on study maintenance and closeout activities, ensuring efficient project execution. The CRA will serve as a primary point of contact for study teams and external partners, supporting essential clinical operations without direct involvement in study startup activities. 
  
Key Responsibilities: 
Oversee study-level project management tasks, including study maintenance, data lock, closeout, document review, and budget monitoring. 
Act as the primary liaison between internal study teams and external third-party organizations (TPOs). 
Track and monitor safety, biomarker, pharmacokinetic (PK), anti-drug antibody (ADA) samples, imaging data, and connected device data. 
Manage and track clinical queries to ensure timely resolution. 
Collaborate with internal teams to align clinical research processes and operational strategies. 
Coordinate with business partners and TPOs to facilitate data delivery and ensure compliance with study requirements. 
 
Minimum Qualifications: 
Bachelor’s degree in a relevant field. 
6+ years of experience in clinical research or a related industry. 
Experience as a Clinical Research Associate, Clinical Research Coordinator, or Clinical Research Assistant. 
3+ years of experience in project management or a related role. 
Prior experience in pharmaceutical, diagnostics, or CRO environments. 
Strong organizational skills with attention to detail. 
Ability to effectively communicate with diverse stakeholders. 
Proficiency in Microsoft Excel for data tracking and reporting. 
Experience with clinical trial management tools such as Medidata RAVE, Veeva Vault, Oracle InForm, or similar platforms. 
Familiarity with electronic Trial Master File (eTMF) systems, query management tools, and safety reporting databases. 
Working knowledge of GCP (Good Clinical Practice) guidelines and regulatory compliance requirements. 
 
In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth.  

Be part of our network of Subject Matter Experts.

E-Verify Participation:  
Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify. 


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Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
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